ID

13564

Beskrivning

Study of Clofarabine & Cytosine Arabinoside Therapy for Older Adults With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00081822

Länk

https://clinicaltrials.gov/show/NCT00081822

Nyckelord

Versioner (1)
  1. 2016-02-16 2016-02-16 -
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16 februari 2016

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00081822

Engelsk

Eligibility Acute Myeloid Leukemia NCT00081822

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have newly diagnosed aml (fab classification types m0-m2 or m4-m7 or who classification) excluding acute promyelocytic leukemia (apl) or aml with any of the following chromosomal translocations: t(15;17)(q22;q21); t(11;17)(q23;q21); t(11;17)(q13;q21); t(5;17)(q32;q12)..
Beskrivning

have newly diagnosed aml (fab classification types m0-m2 or m4-m7 or who classification) excluding acute promyelocytic leukemia (apl) or aml with any of the following chromosomal translocations: t(15;17)(q22;q21); t(11;17)(q23;q21); t(11;17)(q13;q21); t(5;17)(q32;q12)..

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0023487
UMLS CUI [3]
C3688712
UMLS CUI [4]
C1515708
UMLS CUI [5]
C2825131
have greater than or equal to 20% blasts in the bone marrow.
Beskrivning

have greater than or equal to 20% blasts in the bone marrow.

Datatyp

boolean

Alias
UMLS CUI [1]
C1982687
have greater than or equal to 20% cellularity in the bone marrow.
Beskrivning

have greater than or equal to 20% cellularity in the bone marrow.

Datatyp

boolean

Alias
UMLS CUI [1]
C1561532
provide written informed consent.
Beskrivning

provide written informed consent.

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
must be 60-75 years of age at diagnosis.
Beskrivning

must be 60-75 years of age at diagnosis.

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have an karnofsky performance status of ≥60.
Beskrivning

have an karnofsky performance status of ≥60.

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
women of childbearing potential (<1 year post-menopausal unless surgically sterilized) and sexually active males must have a negative urine pregnancy test, and agree to use an effective barrier method of birth control (i.e. latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
Beskrivning

women of childbearing potential (<1 year post-menopausal unless surgically sterilized) and sexually active males must have a negative urine pregnancy test, and agree to use an effective barrier method of birth control (i.e. latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0700589
able to comply with study procedures and follow-up examinations.
Beskrivning

able to comply with study procedures and follow-up examinations.

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to registration: parameter required value (is units) renal serum creatinine <1.1 mg/dl hepatic serum bilirubin <2 x uln ast and alt ≤5 x uln uln = institutional upper limit of normal. inclusion laboratory values
Beskrivning

have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to registration: parameter required value (is units) renal serum creatinine <1.1 mg/dl hepatic serum bilirubin <2 x uln ast and alt ≤5 x uln uln = institutional upper limit of normal. inclusion laboratory values

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with pre-existing myelodysplastic syndrome, or with antecedent hematologic disorder of >3 months duration, will be excluded. those with concomitant myelodysplasia/trilineage dysplasia noted at the time of diagnosis of aml will be eligible 74
Beskrivning

patients with pre-existing myelodysplastic syndrome, or with antecedent hematologic disorder of >3 months duration, will be excluded. those with concomitant myelodysplasia/trilineage dysplasia noted at the time of diagnosis of aml will be eligible 74

Datatyp

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0018939
have secondary aml (aml following chemotherapy or radiation therapy).
Beskrivning

have secondary aml (aml following chemotherapy or radiation therapy).

Datatyp

boolean

Alias
UMLS CUI [1]
C0280449
have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
Beskrivning

have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
have a psychiatric disorder(s) that would interfere with consent, study participation or follow-up.
Beskrivning

have a psychiatric disorder(s) that would interfere with consent, study participation or follow-up.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
are receiving other chemotherapy or corticosteroids (unless the latter is administered at a low dose for pre-medication purposes or for the treatment of chronic conditions - e.g., rheumatoid arthritis).
Beskrivning

are receiving other chemotherapy or corticosteroids (unless the latter is administered at a low dose for pre-medication purposes or for the treatment of chronic conditions - e.g., rheumatoid arthritis).

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0001617
have received prior treatment for leukemia. patients who have received growth factors, cytokine support, leukapheresis, hydroxyurea, or cranial irradiation will be allowed but must discontinue treatment at least 24 hours prior to beginning treatment with clofarabine. if used, hydroxyurea must be discontinued 48 hours prior to the initiation of chemotherapy.
Beskrivning

have received prior treatment for leukemia. patients who have received growth factors, cytokine support, leukapheresis, hydroxyurea, or cranial irradiation will be allowed but must discontinue treatment at least 24 hours prior to beginning treatment with clofarabine. if used, hydroxyurea must be discontinued 48 hours prior to the initiation of chemotherapy.

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0018284
UMLS CUI [3]
C0199974
UMLS CUI [4]
C0023416
UMLS CUI [5]
C0020402
UMLS CUI [6]
C0079172
have any other severe concurrent disease (severe coronary artery disease (nyha class >ii), significant neurological disorder, uncontrolled diabetes, etc.), which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Beskrivning

have any other severe concurrent disease (severe coronary artery disease (nyha class >ii), significant neurological disorder, uncontrolled diabetes, etc.), which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
have active central nervous system involvement with leukemia.
Beskrivning

have active central nervous system involvement with leukemia.

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
other malignancy within the past year, with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin
Beskrivning

other malignancy within the past year, with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Acute Myeloid Leukemia NCT00081822

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
have newly diagnosed aml (fab classification types m0-m2 or m4-m7 or who classification) excluding acute promyelocytic leukemia (apl) or aml with any of the following chromosomal translocations: t(15;17)(q22;q21); t(11;17)(q23;q21); t(11;17)(q13;q21); t(5;17)(q32;q12)..
boolean
C0023467 (UMLS CUI [1])
C0023487 (UMLS CUI [2])
C3688712 (UMLS CUI [3])
C1515708 (UMLS CUI [4])
C2825131 (UMLS CUI [5])
blasts in the bone marrow
Item
have greater than or equal to 20% blasts in the bone marrow.
boolean
C1982687 (UMLS CUI [1])
cellularity in the bone marrow
Item
have greater than or equal to 20% cellularity in the bone marrow.
boolean
C1561532 (UMLS CUI [1])
informed consent
Item
provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
age
Item
must be 60-75 years of age at diagnosis.
boolean
C0001779 (UMLS CUI [1])
karnofsky performance status
Item
have an karnofsky performance status of ≥60.
boolean
C0206065 (UMLS CUI [1])
pregnancy and contraception
Item
women of childbearing potential (<1 year post-menopausal unless surgically sterilized) and sexually active males must have a negative urine pregnancy test, and agree to use an effective barrier method of birth control (i.e. latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
compliance
Item
able to comply with study procedures and follow-up examinations.
boolean
C1321605 (UMLS CUI [1])
organ function
Item
have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to registration: parameter required value (is units) renal serum creatinine <1.1 mg/dl hepatic serum bilirubin <2 x uln ast and alt ≤5 x uln uln = institutional upper limit of normal. inclusion laboratory values
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
myelodysplastic syndrome or with antecedent hematologic disorder
Item
patients with pre-existing myelodysplastic syndrome, or with antecedent hematologic disorder of >3 months duration, will be excluded. those with concomitant myelodysplasia/trilineage dysplasia noted at the time of diagnosis of aml will be eligible 74
boolean
C3463824 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
secondary aml
Item
have secondary aml (aml following chemotherapy or radiation therapy).
boolean
C0280449 (UMLS CUI [1])
systemic infection
Item
have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
boolean
C0009488 (UMLS CUI [1])
psychiatric disorder(s) that would interfere with consent, study participation or follow-up
Item
have a psychiatric disorder(s) that would interfere with consent, study participation or follow-up.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
chemotherapy or corticosteroids
Item
are receiving other chemotherapy or corticosteroids (unless the latter is administered at a low dose for pre-medication purposes or for the treatment of chronic conditions - e.g., rheumatoid arthritis).
boolean
C0392920 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
prior therapy for leukemia
Item
have received prior treatment for leukemia. patients who have received growth factors, cytokine support, leukapheresis, hydroxyurea, or cranial irradiation will be allowed but must discontinue treatment at least 24 hours prior to beginning treatment with clofarabine. if used, hydroxyurea must be discontinued 48 hours prior to the initiation of chemotherapy.
boolean
C1514463 (UMLS CUI [1])
C0018284 (UMLS CUI [2])
C0199974 (UMLS CUI [3])
C0023416 (UMLS CUI [4])
C0020402 (UMLS CUI [5])
C0079172 (UMLS CUI [6])
severe concurrent disease
Item
have any other severe concurrent disease (severe coronary artery disease (nyha class >ii), significant neurological disorder, uncontrolled diabetes, etc.), which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
cns leukemia
Item
have active central nervous system involvement with leukemia.
boolean
C1332884 (UMLS CUI [1])
malignancy
Item
other malignancy within the past year, with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
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